Eye Health Intervention Study in Upper Manhattan (EYES-UM)

Columbia University

Status: Begins enrollment in 1 month

Conditions: Vision Impairment and Blindness; Refractive Errors; Cataract; Glaucoma, Suspect; Diabetic Retinopathy

Treatments: Other: Intervention; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06112431

PA-25-305 (Other Grant/Funding Number)

AAAV6542

Details and patient eligibility

About

Individuals living in Upper Manhattan have limited access to eye care, high vision impairment rates, and poor ocular health outcomes. To improve eye care and vision health outcomes, the Eye Health Intervention Study in Upper Manhattan (EYES-UM) will conduct eye health screenings in accessible primary care health centers and senior centers and implement a behavioral intervention to improve adherence for those referred for in-office eye care. The proposed innovative, 2:1 cluster-randomized clinical trial, will recruit adults age 40 and older in Upper Manhattan with known rates of inadequate eye care. A total of 10 settings in Upper Manhattan, comprised of primary care offices, senior centers, and organizations, confirms access to 17,000 individuals living at or below the NYC.gov poverty measure. This study will conduct ocular tests (visual acuity, intraocular pressure, fundus images) during screenings. To ensure that all participants receive the basic level of service, all participants who fail the eye health screening will be seen the same day by a study optometrist and eyeglasses will be provided at no charge. Educational workshops and an Advisory Board will support recruitment. Intervention Arm participants will receive ongoing support with scheduling eye exams and transportation by trained Study Coordinators. All participants will be followed prospectively for 2 years. The study is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework. Conducting Focus Groups with health policy stakeholders ensures iterative input during the study to bridge and translate EYES-UM findings into a Vision Health Policy Roadmap for scalable implementation of vision care delivery models, focusing on adherence.

Full description

Populations in urban settings such as Upper Manhattan, have limited access to eye care, high vision impairment rates, and poor ocular health outcomes. Our team of vision researchers designed the Eye Health Intervention Study in Upper Manhattan (EYES-UM) to provide eye health screenings directly in Upper Manhattan, in familiar and accessible settings. The proposed innovative, 2:1 cluster-randomized clinical trial, will recruit adults age 40 and older in Upper Manhattan with high rates of inadequate eye care.

A total of 10 settings in Upper Manhattan, comprised of health centers and senior centers, confirms access to 17,000 individuals. This study will conduct ocular tests (visual acuity, intraocular pressure, fundus images) during screenings. To ensure that all participants receive the basic level of service, all participants who fail the eye health screening will be seen the same day by a study optometrist and eyeglasses will be provided at no charge. Educational workshops and an Advisory Board will support recruitment. Intervention Arm participants will receive ongoing support with scheduling eye exams and transportation by trained study coordinators. All participants will be followed prospectively for 2 years. The study is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework: In Aim 1, we will evaluate the effectiveness of an Eye Health Intervention to improve access to vision health services in 10 settings in Upper Manhattan. After eye health screenings and optometric exams, we will conduct a 2:1 cluster-randomized clinical trial using an Intervention to provide eye exam scheduling and transportation for those referred to ophthalmology to improve in-office eye exam adherence behavior over 2 years (primary implementation outcome) and eye disease detection (primary clinical effectiveness outcome). In Aim 2, using the RE-AIM Framework, we will evaluate the implementation of the Eye Health Intervention using mixed-methods. Aim 3 includes a proactive implementation science approach to produce a real-world Vision Health Policy Roadmap by conducting Focus Groups with health policy stakeholders to understand evidence needed to develop scalable and sustainable nationwide vision care delivery models and how to incentivize payors to ensure the success of these efforts. The Eye Health Intervention will protect and improve vision health outcomes and provide a sustainable model that can be scaled-up in many settings. By providing basic eye care services and eyeglasses to all participants, simplifying access and supporting utilization of in-office eye care, this innovative research strategy will generate important evidence and a roadmap for policy change to advance vision health. This innovative approach using Focus Groups ensures iterative input during the study to bridge and translate EYES-UM findings into a Vision Health Policy Roadmap for scalable implementation of vision care delivery models, focusing on adherence.

Enrollment: 5,840 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals age 40 years or older.
• Living independently.

Exclusion criteria

• Self-reported terminal illness with life expectancy of less than 1 year.
• Inability to provide informed consent due to dementia or other reason.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5,840 participants in 2 patient groups, including a placebo group

Intervention Arm

Experimental group

Description:

Participants randomized to the Intervention Arm and referred to ophthalmology will receive assistance from a Study Coordinator with scheduling in-office eye exam appointment and arranging transportation to these appointments over 2 years at either Columbia Ophthalmology, Harlem Hospital, or their own eye care provider.

Treatment:

Other: Intervention

Usual Care

Placebo Comparator group

Description:

Consented participants randomized to the Usual Care Arm will receive all the basic level of services including the eye health screening, optometric exam if they fail the screening, and eyeglasses at no charge. Those who require referral to ophthalmology will be scheduled for the initial in-office eye exam and their outcomes will be tracked. No additional support will be provided the Usual Care participants during the study. The Usual Care Arm represents a realistic choice currently available for participants following eye health screening.

Treatment:

Other: Usual Care